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Fibreoptic Intubation With and Without Sellick´s Maneuver

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bjorn Arenkiel, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01357824
First received: May 19, 2011
Last updated: January 29, 2012
Last verified: January 2012
  Purpose

The goal of this study is to evaluate the effect of Sellick´s Maneuver, a firm pressure on the throat, just below the Adams apple, to occlude the esophagus, in order to prevent aspiration of gastric contents, on intubation with a flexible fiberscope. The result of this study will be participate in the discussion of the importance of Sellick´s Maneuver.


Condition Intervention
Intubation Intraesophageal
Respiratory Aspiration of Gastric Contents
Procedure: Application of Sellick´s maneuver.

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: View af Larynx and Intubation With a Flexible Fibreoptic Scope With and Without Sellick´s Maneuver.

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Time of intubation [ Time Frame: 180 seconds ] [ Designated as safety issue: Yes ]
    The investigators will find an eventually change in the time of intubation with and without Sellick´s Maneuver


Secondary Outcome Measures:
  • Number of patients that cannot be intubated after 120 sec. with and without Sellick´s maneuver [ Time Frame: 180 seconds ] [ Designated as safety issue: Yes ]
    Patients that is not intubated after 120 seconds in each trial, will count as "not intubated after 120 seconds".

  • Fall of oxygen saturation after intubation with and without Sellick´s maneuver. [ Time Frame: 180 seconds ] [ Designated as safety issue: Yes ]
    The investigators measure the oxygen saturation on a finger device at the beginning and the and of the intubations.

  • Visualization of the vocal cords [ Time Frame: 180 seconds ] [ Designated as safety issue: Yes ]
    The investigators will observe the visualization of the vocal cords, and provide the result on the Cormack Score.


Estimated Enrollment: 50
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients admitted for elective surgery
The patient admitted for elective surgery can be included, and will both the case and control, as we intubate the same patient twice, with and without Sellick´s maneuver.
Procedure: Application of Sellick´s maneuver.
The patient will be intubated with a flexible fiberscope, Olympus model, under the application of Sellick´s maneuver, with the recommended 30 Newtons pressure, and also, as control, be intubated with a sham Sellick´s maneuver, with 0 Newton. The order of the pressures is randomized, and it is blinded to the intubating physician by a cloth which of the maneuvers that is used. The pressure is measured be a pediatric cuff, which is pressed against the throat.

Detailed Description:

The patients included in this study has volunteered after sufficient information, and must be ASA-class I-II, 18 years or more, and must not have indications for a rapid sequence induction.

The patient will be intubated twice, with and without Sellick´s maneuver. It is blinded to the intubating physician, in which order this pressure is applied.

The outcomes measures will be time of intubation, oxygen saturation before and after intubation and a Cormack Scale graduation of the visibility of the vocal cords. The intubation will be failed, if it cannot be performed under 120 seconds, or if the patients desaturate to 95% or less.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted for elective surgery at Glostrup University Hospital

Criteria

Inclusion Criteria:

  • ASA I-II
  • Informed consent to participate in the study
  • Age 18 or older
  • Predicted difficult airways

Exclusion Criteria:

  • Body mass index more then 35
  • Patients with an indication for a rapid sequence induction (reflux, Hiatus herniation, Gastric bypass)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357824

Locations
Denmark
Operations- og Anæstesilogisk afd Y, Glostrup Hospital
Glostrup, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Bjørn Arenkiel, MD Glostrup University Hospital, Copenhagen
  More Information

Publications:
Responsible Party: Bjorn Arenkiel, Reservelæge, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01357824     History of Changes
Other Study ID Numbers: Glostrup Crich Study
Study First Received: May 19, 2011
Last Updated: January 29, 2012
Health Authority: Denmark: Datatilsynet

Keywords provided by Glostrup University Hospital, Copenhagen:
Intubation
Sellick´s maneuver
aspiration
[E05.497.578]

Additional relevant MeSH terms:
Respiratory Aspiration
Respiratory Aspiration of Gastric Contents
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastroesophageal Reflux
Gastrointestinal Diseases
Laryngopharyngeal Reflux
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014